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Are you currently (or have you been) in a Clinical Trial?

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  • ShetlandPony
    ShetlandPony Member Posts: 3,063

    Oh, Leftfootforward, what an unimaginably difficult situation! How stressful and scary. Of course you want to live with your husband, and the kids want their dad. As an ER doc, he will be among the very first to get the vaccine, right? Until then, I wish there was some really great person who is also very careful, who could join your bubble and be a nanny/mother’s helper.

  • bsandra
    bsandra Member Posts: 1,023

    Dear LFF, my prayers go out to you and your husband. Let you all be safe and covid-19 free.

    I was also wondering... if covid-19 vaccine could do something good in treating cancers? Well, I mean... they use many tools acquired in cancer immunology research to create these mRNA vaccines, they equip T-cells with proteins to recognize covid-19, so... if we infect people with covid-19, cancer cells would also get infected, and these T (or B) cells would come and destroy these cancer-cells along with other cells... anyway, that is how some oncolytic viruses work in cooperation with some drugs... It all got to me straight from the beginning, as covid-19 came, especially with these WBC accumulations in lungs that destroy lungs with covid-19... if that process could be "controlled", metastases could also be destroyed... anyway, I am not a medical scientist here but is there some credibility in all of this? I tried to search for such info some time ago but obviously the world is now more concerned to first eliminate covid-19, so cancers come last, as always...

    Saulius

  • sondraf
    sondraf Member Posts: 1,665

    BSandra - this was something I raised over the summer in another thread (Ibrance maybe) about how speed and collaboration, while it may be focused on Covid right now - what could fall out the back of this accelerated process, across all these pharmas? A ton of data had to have been generated, or observations made, that could prompt other thought in other areas. Or if new processes for trial and regulatory approval, developed to support Covid, will help get other advantageous drugs to market faster? Maybe this is the catalyst to break up the existing incremental MBC pipeline development, who knows.

  • [Deleted User]
    [Deleted User] Member Posts: 760

    clinical trial news for Neuroendocrine breast cancer

    https://clinicaltrials.gov/ct2/show/NCT04276597

    This is one of the first Neuroendocrine focused trials that contains actual verbiage to include the breast.

    I tried to get on the list but they said no because I take IVIG. I may retry again in the future.

    Dee

    (Also posted this to Neuroendocrine thread

  • husband11
    husband11 Member Posts: 1,287

    Saulius, take a look at my post on complementary therapy, on the topic of the oral cholera vaccine and breast cancer. I heard about it over a year ago, when I read that a colorectal cancer patient's oncologist recommended it for him. So it got me thinking. Cause and effect isn't proven, but an analysis of patients of first colon, then prostate and now breast cancer, shows increased survival. Could the cholera vaccine be stimulating some immune response against some breast cancers?

  • olma61
    olma61 Member Posts: 1,026

    Saulius, yes to what you say here, I have the same hope. When I listened to a description of how coronavirus behaves and replicates, I was struck by how similar it is to cancer cells. Maybe something for us comes out of the COVID research too. 🙏🏼

  • nicolerod
    nicolerod Member Posts: 2,877

    Husband but could that work on someone already having metastasis or just to prevent?? That is like Hydroxcholoquine..(before COVID) if ya remember it was in trials at MSK for Early Stage BC...to prevent Mets....I don't know that it works the same if you already have Stage 4...people include it on Metro Map (Jane Mcclelland) anyway....

    But my bigger concern is taking ANY vaccine while having Stage 4 and being immunocompromised .......

    On a side note..I think I would be willing to get infected with measeals to kill my cancer...thats also been done...

  • candy-678
    candy-678 Member Posts: 4,166

    Nicole- Interesting about hydroxychloroquine in trials to prevent mets. I was on hydroxychloroquine for rheumatoid arthritis (Plaquenil) when we found the mets. I started the drug in 2014 and was diagnosed MBC in 2017.

  • husband11
    husband11 Member Posts: 1,287

    The same study also looked at anti-malarial meds post breast cancer diagnosis, and found no increased rate of survival. They did that to rule out that maybe travellers as a group had some advantage, such as socioeconomic status. Only the cholera vaccine recipients received a 47% increased rate of disease specific survival. The same 47% advantage was seen in prostate and colorectal cancer patients who received the vaccine post diagnosis. Since they died of metastatic breast cancer, and the vaccine was received post diagnosis, the cholera vaccine is either associated with less metastasis, or lower rate of lethality of that metastasis.

    Dukoral, which only contains inactivated cholera virus, is in fact recommended for immunocompromised travelers, aids and transplant patients.

    http://www.bccdc.ca/resource-gallery/Documents/Training%20and%20Events/Immunization/Promotion/1Stiverimmunizationoftheimmunocompromisedpatientrevised.pdf

    https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2007-33/immunocompromised-traveller.html

  • nicolerod
    nicolerod Member Posts: 2,877

    Very interesting Husband11....so we should all be looking at Cholera vaccine I guess?


  • husband11
    husband11 Member Posts: 1,287

    It's impossible to say if the vaccine caused the increased survival, but given that some US oncologists are recommending it for their colorectal patients based on the observations, and that now its been show to be associated with the same advantage in prostate and breast cancer, my wife will be taking it. It's relatively cheap, taken orally, and here in Canada, its over the counter.

    Dukoral is the one you want (dead virus plus recombinant cholera toxin), if you want to try it. I would definitely run it past your Doctor to get their opinion on whether it poses any risk.

  • nicolerod
    nicolerod Member Posts: 2,877

    Did you wife also take flu vaccine? I haven't taken any vaccines...

  • husband11
    husband11 Member Posts: 1,287

    Yes, she just got the flu vaccine yesterday. There is a shortage of it here. She ran it past cancer care, and they told her to get the flu vaccine.

  • BevJen
    BevJen Member Posts: 2,341

    Nicole,

    I always get a flu shot, and this year was no exception.

    Additionally, since I'm "of the age" I've also gotten the two doses on the Shingrix shot (for shingles). No bad reactions to either.

  • moth
    moth Member Posts: 3,293

    hey guys, so I signed my consent for the radiation trial today. 2:1 randomization for sabr v standard rads to treat my lung met (they will also offer to treat any other met that crops up in future separate from any treatment changes the MO wants to make) The RO explained things thoroughly and I feel good about the decision. Even if I'm in control arm, he will treat aggressively. Randomization will happen within a couple weeks. I will have some onboarding appointments for this trial and at the same time additional appointments offboarding from Roche's ipatunity trial.

    The appointments get to be a drag after a while & I guess I'd say they're the major downside to participating in a clinical trial.

    Oh & I had my flu shot a couple weeks ago 😊

  • bsandra
    bsandra Member Posts: 1,023

    Yes, Husband, I remember you writing about cholera vaccine (it is in my "favorites" if something), thanks again. Mechanism of action is not clearly known but it is a bit similar to what I was considering. The only difference how they employ oncolytic viruses is that they actually infect you with the virus and then use vaccine to kill the cells that are infected with the virus (cancer cells get almost equally infected - that is the idea), whereas cholera vaccine seems to work by forming "something" on dendritic cells' and other immune cells' surfaces, so that they start to recognize cancer cells for some reason without man-made vector in these cells. Of course, the second mechanism of action is probably better but difficult to understand and research, while oncolytic virus is the direct vector-target for immune system. My idea was... let's say we have a lung met, and lung is heavily attacked by Covid-19, so met is also infected but your immune system is trained to detect all cells with Covid-19 and to kill them, metastases among them. The problem here I see is that vaccines are made "to prevent" and not "cure", so probably this would not work, because you'd have to infect someone with Covid-19 first, so that mets get infected with the virus, and only later get a vaccine shot to train immune system to kill already existing infection. Vaccines are usually not effective in treatment, they are effective in prevention, i.e. disarm small amounts of infection, so that you would not get ill. But oncolytic viruses are meant to infect and vaccines against them are meant to kill the infected cells, that is how they differ from usual vaccines. Yes, probably nothing will come out of Covid-19 for cancer:/ Saulius

  • susaninsf
    susaninsf Member Posts: 1,099

    Debu Tripathy (Chair of Breast Cancer Oncology at MD Anderson) came out with a podcast on OncLive that I thought was really informative for ER+/HER2- breast cancer.

    https://www.onclive.com/view/tripathy-talks-genomics-targeted-treatments-and-smart-trial-designs-in-breast-cancer

  • BevJen
    BevJen Member Posts: 2,341

    SusaninSF,

    Thanks for posting that. It was a really interesting podcast, chock full of information.

  • cure-ious
    cure-ious Member Posts: 2,854

    LFF, That sounds exhausting and scary in every direction you turn! I wanted to make sure you saw the recent reports that found that people taking the sleep supplement melatonin had far fewer Covid infections (which were reduced by more than half for black patients! and was like 35% overall, it's seemingly a huge effect!), and I'm sure you know about the vitamin D, baby aspirin, pepcid AC, zinc lozenges, etc.. Melatonin is the first thing I've seen recommended to prevent infection rather than treat early infections..We all gotta stay clear just a little bit longer, till the vaccine gets here!!

    https://www.fiercebiotech.com/research/does-sleep-aid-melatonin-work-as-a-covid-19-treatment


  • cure-ious
    cure-ious Member Posts: 2,854

    SusaninSF, thanks for the podcast! It's uplifting to occasionally hear about what is on the horizon, it so rarely permeates into the public sphere. So, he mentioned mutations in Paf1 and Paf3 transcription factors, SR splicing factors, or Jak/Stat pathway Stat3 transcription factor as being novel ways they are seeing where cancers are resisting Ibrance. He said Stat3 inhibitors will go into trials with Ibrance, for example. And then also how the liquid biopsy is now being used to track cancers as they mutate and become resistant during clinical trials, and also using them to follow early stage cancer patients, so they can try to squelch metastases before they even show up on a scan. Exciting stuff!!!

  • leftfootforward
    leftfootforward Member Posts: 1,396

    thank you cute-iou

  • cure-ious
    cure-ious Member Posts: 2,854

    A review of treatments for ER-positive MBC:https://www.targetedonc.com/view/expert-reviews-no...

    They mention a SERD from AstraZeneca, called AZD9833, which is being tested in the SERENA-1 (alone or in combination with Ibrance or everolimus) and SERENA-2 trials (comparing three different dose levels vs fulvestrant), with early results indicating it has activity at all doses and works on ER-dependent or ESR1 mutant cancers, for patients who progressed on I/F. Being that its AstraZeneca and still early stages, trial sites are mainly in the UK and europe, but a handful are in the US or Canada...

    https://clinicaltrials.gov/ct2/show/NCT03616587

    https://clinicaltrials.gov/ct2/show/NCT04214288#co...

  • nicolerod
    nicolerod Member Posts: 2,877

    Thanks for that Cureious :)


  • BevJen
    BevJen Member Posts: 2,341

    Cure-ious,

    I also thought that the talk about CDK7 in that article was very interesting, as well as the discussion about triplets.

    Thanks much for posting.

  • tinkerbell107
    tinkerbell107 Member Posts: 292

    Cure-ious: Thank you for bringing forth the information on the SERENA trials.

    In reviewing the eligibility, if you've been on Fulvestrant this disqualifies for you to participate. My question is for folks that have not been on Fulvestrant, are you better off trying to get on this clinical trial vs. going with a 2nd line treatment that typically has Fulvestrant. In my situation, my MO will likely recommend PIqray with the Fulvestrant due to having a PIK3CA mutation. Just trying to think a head with options. I'm with-in 4 hrs of one of the facilities that offer the Serena trial. So it could be doable. Just wondering if anyone else is leaning in this direction.


  • BevJen
    BevJen Member Posts: 2,341

    Tinkerbell107,

    I am not in your exact situation, but I have been tossing around sequencing with my MO and my consulting MO for a bit.

    I would talk with your MO. At some centers, they have a molecular tumor board that focuses on genomic reports (including mutations, as you've mentioned) and makes recommendations about possible sequencing of drugs. That is the situation at my cancer center. I, too, have the Pik3CA mutation, so piqray is also on my list of future drug possibilities, along with other drugs. My MO is also not averse to me trying to participate in a clinical trial that might offer other drug possibilities. That's as far as our conversation has gone currently.

    There are so many variables in each of our cancers that I don't know how easy sequencing is to figure out. I think every clinician is trying to do that, but it's not as easy as we might think.

    Good luck.

  • tinkerbell107
    tinkerbell107 Member Posts: 292

    BevJen: Yes, I agree the sequencing is a challenge. My facility has a molecular tumor board but I'll probably go to another institution that is a larger academic facility for a 2nd opinion. My MO is conservative, meaning she will go with what is already studied rather then recommend a clinical trial. We briefly had this conversation prior to my last PET scan, and was practically sold on PIqray, which I'm not presently. I would rather try a SERD before jumping to Piqray.

  • BevJen
    BevJen Member Posts: 2,341

    Tinkerbell,

    Excellent points and ones that I agree with. My center is currently running zippo trials on immunotherapy in breast cancer, though they have a whole department supposedly tasked with studying this. What's that all about?

    And as for Piqray, I am like you. I am NOT sold on piqray. Even the nurse who gives me my faslodex shots told me that she's not met one person who is on piqray who is dealing with it well. In reading the boards here, some people are doing okay, but it seems to require lower dosages than those originally tested. I've told my MO that I would only go on that drug if she would titrate upwards, not wait until the inevitable SEs show up and then decrease the dosage. I haven't gotten her response to that yet -- she, too, is conservative and I don't think she will go for it.

    And yes, the SERDs look really promising, as well as some of the triplet combos now currently being tested in clinical trials.

    I am periodically "seeing" (because it's all been Telehealth) another MO to throw the spaghetti on the wall and see what sticks. I think that's a good approach.

  • cure-ious
    cure-ious Member Posts: 2,854

    Tinkerbell,

    The exclusion for those having taken Faslodex is only for the Serena-2 trial, which makes sense because its testing the SERD as monotherapy, and the control arm is Faslodex alone.

    Serena-1 is the more attractive trial, testing the SERD alone (single dose) or in combination with Ibrance or Everolimus. I don't think prior Faslodex matters in this trial, but the bigger problem is its only currently at four US locations (FLA, TN, CO, UT).. However, its very big for a phase one trial (270 participants) so maybe there will be more locations open up...

    https://clinicaltrials.gov/ct2/show/NCT03616587


  • tinkerbell107
    tinkerbell107 Member Posts: 292

    Cure-ious: Thanks for pointing that out re the Fulvestrant, must of misread it. Let's hope the trial opens more sites.